Exercise and Stress Management Post Autologous and Allogeneic Transplant (BMT CTN 0902)

NCT ID: NCT01278927

Last Updated: 2022-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 711 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2014-11-30

Brief Summary

This is a Phase III, randomized, unblinded, multicenter, prospective comparative study. The purpose of this study is to test whether exercise or stress management training delivered to autologous and allogeneic hematopoietic cell transplantation (HCT) patients prior to transplantation can improve functional status and the transplant experience.

Detailed Description

Background:

The adverse effects of hematopoietic cell transplantation (HCT) on short and long term quality of life are well documented. Patients experience numerous aversive symptoms (e.g., nausea, fatigue, and sleep disturbance) that are accompanied by declines in physical and mental well-being. Although most longitudinal studies show return to baseline functioning for the majority of patients, it may take 6 to 12 months or longer to reach this goal. Clinical trials have shown that training in stress management techniques and participation in formal exercise programs each offered in isolation are effective in improving quality of life in patients receiving standard-dose chemotherapy and HCT. Review of these studies suggests that stress management interventions primarily improve mental health outcomes and nausea. The impact of exercise training interventions is more variable; most studies report physical health benefits, with some studies also reporting mental health benefits. Small studies suggest that combining stress management training and exercise are feasible and well-tolerated, but whether the combination provides an additive or synergistic impact on quality of life outcomes has not been directly investigated.

Design Narrative:

The protocol is designed as a factorial trial with two interventions, exercise and stress management, which results in four treatment arms: standard care, exercise only, stress management only and the combination of exercise and stress management. The primary objective of this randomized phase III trial is to test the ability of exercise training or stress management training to improve physical and mental functioning at Day 100 post hematopoietic cell transplantation.

Conditions

Physiological Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Exercise

Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief (10 minute) personalized introduction to the home-based exercise intervention. On Day 30 post hematopoietic cell transplantation (HCT), participants will meet briefly with the same interventionist when possible. To minimize contamination across intervention conditions, participants randomized to Exercise will be provided with only general advice regarding stress management (i.e., to continue using any techniques they currently use to manage stress). The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: BEHAVIORAL

Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.

Stress Management

Participants will receive a packet of materials from the study interventionist, along with a brief standardized introduction to the self-administered intervention. On Day 30 post HCT, the interventionist will meet with the participant to answer any questions about the intervention, encourage the continued use of stress management techniques as recommended, and monitor for any adverse reactions to use of the techniques. The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant. Whenever possible, the interventionist meeting with the patient at 30 and 60 days should be the same interventionist who previously met with the patient.

Group Type: ACTIVE_COMPARATOR

Stress Management

Intervention Type: BEHAVIORAL

Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.

Exercise and Stress Management

Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions. On Day 30 post HCT, the same interventionist will meet with the participant briefly to answer any questions about the interventions, encourage the continued use of the interventions as recommended, and monitor for any adverse reactions. The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant. Whenever possible, the interventionist meeting with the patient at 30 and 60 days should be the same interventionist who previously met with the patient.

Group Type: ACTIVE_COMPARATOR

Exercise and Stress Management

Intervention Type: BEHAVIORAL

Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.

Standard Care

Patients randomized to standard care only will be informed of their assigned condition and receive a digital video disc (DVD). The interventionist will briefly discuss the topics of the DVD and elicit questions. To minimize contamination across intervention conditions, participants randomized to the control group will be provided with only general advice about exercise and stress management during treatment (i.e., to maintain any usual patterns of exercise to the extent possible and to continue using any techniques they currently use to manage stress).

Group Type: OTHER

Standard Care

Intervention Type: OTHER

Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.

Interventions

Exercise

Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.

Intervention Type: BEHAVIORAL

Stress Management

Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.

Intervention Type: BEHAVIORAL

Exercise and Stress Management

Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.

Intervention Type: BEHAVIORAL

Standard Care

Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.

Intervention Type: OTHER

Other Intervention Names

Physical activities; Musculoskeletal; Exertian level; Active relaxation; Deep breathing; Positive thinking; Relaxing; Physical and emotional relaxation; Active relaxation; General care; Psychosocial care

Eligibility Criteria

Inclusion Criteria

• Age 18 years or older
• Able to speak and read English
• Able to exercise at low to moderate intensity - adequate cardiopulmonary reserve, as judged by self-reported ability to walk up one flight of stairs, no requirement for supplemental oxygen, and physician judgment
• Willing and able to provide informed consent.
• Stated willingness to comply with study procedures and reporting requirements
• Planned autologous or allogeneic transplantation within 6 weeks.

Exclusion Criteria

• Orthopedic, neurologic or other problems which prevent safe ambulation and protocol adherence
• Participation in another clinical trial with quality of life or functional status as a primary endpoint

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Blood and Marrow Transplant Clinical Trials Network

NETWORK

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

National Marrow Donor Program

OTHER

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary Horowitz, MD

Role: STUDY_DIRECTOR

Center for International Blood and Marrow Transplant Research

Locations

City of Hope National Medical Center

Duarte, California, United States

University of Florida College of Medicine

Gainesville, Florida, United States

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

Blood & Marrow Transplant Program at Northside Hospital

Atlanta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Washington University, Barnes Jewish Hospital

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

University Hospitals of Cleveland/Case Western

Cleveland, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

Fox Chase, Temple University

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Baylor College of Medicine/The Methodist Hospital

Houston, Texas, United States

Virginia Commonwealth University, MCV Hospital

Richmond, Virginia, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Countries

United States

References

Jacobsen PB, Le-Rademacher J, Jim H, Syrjala K, Wingard JR, Logan B, Wu J, Majhail NS, Wood W, Rizzo JD, Geller NL, Kitko C, Faber E, Abidi MH, Slater S, Horowitz MM, Lee SJ. Exercise and stress management training prior to hematopoietic cell transplantation: Blood and Marrow Transplant Clinical Trials Network (BMT CTN) 0902. Biol Blood Marrow Transplant. 2014 Oct;20(10):1530-6. doi: 10.1016/j.bbmt.2014.05.027. Epub 2014 Jun 6.

Reference Type: RESULT

PMID: 24910380 (View on PubMed)

Wood WA, Le-Rademacher J, Syrjala KL, Jim H, Jacobsen PB, Knight JM, Abidi MH, Wingard JR, Majhail NS, Geller NL, Rizzo JD, Fei M, Wu J, Horowitz MM, Lee SJ. Patient-reported physical functioning predicts the success of hematopoietic cell transplantation (BMT CTN 0902). Cancer. 2016 Jan 1;122(1):91-8. doi: 10.1002/cncr.29717. Epub 2015 Oct 6.

Reference Type: RESULT

PMID: 26439325 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

U01HL069294

Identifier Type: NIH

Identifier Source: secondary_id

View Link

BMT CTN 0902

Identifier Type: OTHER

Identifier Source: secondary_id

5U24CA076518

Identifier Type: NIH

Identifier Source: secondary_id

View Link

BMTCTN0902

Identifier Type: -

Identifier Source: org_study_id